The U.S. Supreme Court may be able to help Teva Pharmaceutical Industries over a patent dispute on a key drug used to treat multiple sclerosis (MS).
Teva is trying to keep other companies from providing cheaper generics as an option to Copaxone (Glatiramer acetate). The new alternatives could be offered to patients as soon as May, when Copaxone is scheduled to lose its patent protection.
The appeal comes after a lower court, the Court of Appeals for the Federal Circuit, invalidated a patent that protected Copaxone until September 2015. The patent was to expire on Sept. 1 of that year and claims a process for manufacturing the active ingredient in Copaxone.
The case is being watched carefully by those with MS and their physicians.
“Glatiramer acetate … is a long-established disease modifying therapy (DMT) for multiple sclerosis, approved by the FDA in 1996,” Dr. John R. Corboy, who teaches at the University of Colorado School of Medicine and is co-director of the Rocky Mountain MS Center, explained in an e-mail to InsideCounsel. “It remains the most used DMT for MS, and has remained a very profitable medication for Teva for many years.”
“All the approved medications for MS are very expensive, and every time a new drug becomes available, the prices of all the meds go up,” he adds. “Thus, it would be of great interest to have price competition for our medications, and the prospect of a generic version of GA, or any MS med, being available is quite appealing. This, of course, assumes the generic GA is equivalent to Copaxone, and that it can be consistently and reliably produced.”
"Copaxone is one of 10 branded products that are approved for the treatment of MS in reducing relapses (and for some of them, disability, as well). There has not yet been a generic medication available for MS, and if Copaxone becomes generic, then it will be the first. There is a question about whether it is possible to make a genetic for Copaxone, which is a complex molecule, without testing it in large clinical trials in humans,” added Daniel Kantor, MD, a member of the Healthcare Advisory Panel of the Multiple Sclerosis Foundation and the Immediate Past President of the Florida Society of Neurology.
The New York Times reports that list prices of Copaxone and some other older MS medications have quadrupled over about 10 years. They now cost about $60,000 a year.
It is noteworthy that Teva was reported to be “the world’s largest maker of generic drugs,” according to The Times. “But Teva is now emulating its rivals, mounting an aggressive effort to stave off generic versions of Copaxone.” In 2013, Copaxone saw $4.3 billion in global sales. It represents about half of Teva’s profit.
In response to the threat of generic alternatives, Teva wants to soon offer patients a new version of Copaxone that patients would use less frequently. According to the Times, the new version would not be threatened by competition from generics – at least for the time being. The new version is also slightly less expensive per dose.
Teva also wants the Food and Drug Administration (FDA) to reject any generics for Copaxone. Teva claims any generics may not be the same quality as the original drug – because it is so complex. The FDA has yet to rule on the request.
“Any purported generic version of Copaxone would be required to obtain the … FDA's approval prior to being made available to the public,” Teva said in a statement. “The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in … patients.”
On the other hand, the FDA could approve generic alternatives to Copaxone as soon as next month. The generic options come from a partnership between Momenta Pharmaceuticals and Sandoz, as well as a partnership between Mylan and Natco Pharma.
Meanwhile, Teva said in the statement it was “pleased that the Court has agreed to hear its appeal and Teva remains committed to pursuing all options to protect its intellectual property for Copaxone.”
Reuters reported that oral arguments and a ruling are likely to take place not until the Supreme Court’s next term, which starts this coming October and ends in June of next year.
“The Company is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS [Relapsing-remitting multiple sclerosis] patients over the product's lifecycle, given the strength of its intellectual property (IP) rights,” the statement adds.
Overall, the biotech sector has been strong, but there has been some concern that a current “bubble” could be coming to an end, according to InsideCounsel.
Looking at the big picture, too, Robin Feldman, director of the UC Hastings Institute for Innovation Law, said in an e-mail, “Uncertainty has reined in the patent world for some time.”
“One cannot tell what a patent covers, how a court will interpret that coverage, or whether a particular viewpoint will be upheld,” she added. “Uncertainty is never good for a market and certainly had hurt patents and innovation.”
“This cert grant [Teva] is a reminder of the Supreme Court’s strong interest in overseeing the Federal Circuit and improving the patent system,” she explained.